ASSOCIATES OF CAPE COD, INC.

Address:124 Bernard E. Saint Jean Drive,E Falmouth,MA,02536,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Calculator/Data Processing Module, For Clinical Use (JQP) (1)

Premarket Exempt

No Yes

Clear

Fungitell® - 00862696000203 Catalog Number : FT001

Device Description : Assay for (1-3)-β-D-Glucan in Serum

Device Class :

Duns Number: 076574078

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 2

Fungitell® - 00862696000210 Catalog Number : FT001

Device Description : Assay for (1-3)-β-D-Glucan in Serum

Device Class :

Duns Number: 076574078

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 2

Fungitell STAT - 00862696000227 Catalog Number :

Device Class :

Duns Number: 076574078

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

BG Analytics Software - 00862696000289 Catalog Number :

Device Description : a calculator/data processing module for clinical use described as electronic dev a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data.

Device Class : 1

Duns Number: 076574078

Premarket Exempt : Yes

Product Code : JQP

Prescription Use : No

Device Count : 1

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